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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, piston
Product CodeFMF
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURO TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
AEA SRL
  SUBSTANTIALLY EQUIVALENT 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AZUR MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 3
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
BERPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOVENTUS LLC
  SUBSTANTIALLY EQUIVALENT 1
BONE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONUS THERAPEUTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHIRANA T. INJECTA
  SUBSTANTIALLY EQUIVALENT 1
CONTROL MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
DLP MEDICAL PRODUCTS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELCAM MEDICAL ACAL
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FLAT MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG ANTMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUIDESTAR MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
HANTECH MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HWAJIN MEDICAL CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
INSTYLLA, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTERNATIONAL MEDICAL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL MEDICAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CAINA MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JICHUN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU KANGYOU MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU SUYUN MEDICAL MATERIAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU ZHIYU MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI MAIDIKANG MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIFELONG MEDITECH PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
LIFENET HEALTH
  SUBSTANTIALLY EQUIVALENT 1
LINEAGE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MD3 LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDONE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDWELL TECHNOLOGY LTD
  SUBSTANTIALLY EQUIVALENT 1
MILESTONE SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANUM COMPANY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NIPRO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OCUJECT, LLC
  SUBSTANTIALLY EQUIVALENT 2
OMEQ MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORBIT BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERFECT MEDICAL INDUSTRY (VN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
PROSIDYAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
REVITAL HEALTHCARE (EPZ) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG QINKAI MEDICAL INDUSTRY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI KOHOPE MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHINA MED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMB CORPORATION OF INDIA
  SUBSTANTIALLY EQUIVALENT 1
SOL-MILLENNIUM MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
SPM MEDICARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOP CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
US INFUSION INC. D/B/A TRUECARE BIOMEDIX-USA
  SUBSTANTIALLY EQUIVALENT 1
WEIHAI SHENGJIE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WEPON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI NEST BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5862 5863
2020 5330 5330
2021 5868 5871
2022 5233 5233
2023 5222 5222
2024 3625 3625

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 7699 7699
Device Contamination with Chemical or Other Material 4410 4411
Break 3205 3205
Patient Device Interaction Problem 1925 1925
Volume Accuracy Problem 1651 1651
Failure to Deliver 1467 1467
Device Markings/Labelling Problem 1466 1469
Computer Software Problem 1305 1305
Material Too Rigid or Stiff 785 785
Defective Component 731 731
Packaging Problem 711 711
Defective Device 652 652
Fluid/Blood Leak 626 626
Contamination 609 609
Crack 559 559
Detachment of Device or Device Component 464 464
Material Separation 377 377
Material Deformation 353 353
Physical Resistance/Sticking 348 348
Wireless Communication Problem 339 339
Delivered as Unsterile Product 309 309
Appropriate Term/Code Not Available 281 281
Mechanical Jam 277 277
Adverse Event Without Identified Device or Use Problem 277 277
Insufficient Information 261 261
Connection Problem 246 246
Contamination /Decontamination Problem 231 231
Inaccurate Delivery 224 224
Complete Blockage 221 221
Material Puncture/Hole 214 214
Missing Information 200 200
Insufficient Flow or Under Infusion 180 180
Product Quality Problem 169 169
Mechanical Problem 167 167
Manufacturing, Packaging or Shipping Problem 145 145
Material Protrusion/Extrusion 142 142
Failure to Align 139 139
Loose or Intermittent Connection 128 128
Improper or Incorrect Procedure or Method 119 119
Material Twisted/Bent 119 119
Device Damaged Prior to Use 115 115
Illegible Information 103 103
Battery Problem 100 100
Difficult or Delayed Activation 90 90
Dull, Blunt 88 88
Component Missing 78 78
Fracture 75 75
Material Integrity Problem 74 74
Nonstandard Device 71 71
Contamination of Device Ingredient or Reagent 66 66

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16728 16731
No Known Impact Or Consequence To Patient 6457 6457
No Consequences Or Impact To Patient 2514 2514
No Patient Involvement 1612 1613
Hyperglycemia 1525 1525
Insufficient Information 1086 1086
Hypoglycemia 361 361
Needle Stick/Puncture 340 340
No Information 296 296
Pain 138 138
Foreign Body In Patient 116 116
Diabetic Ketoacidosis 102 102
Coma 97 97
Exposure to Body Fluids 77 77
No Code Available 55 55
Underdose 35 35
Missed Dose 34 34
Device Embedded In Tissue or Plaque 34 34
Hemorrhage/Bleeding 34 34
Chemical Exposure 33 33
Bruise/Contusion 31 31
Loss of consciousness 27 27
Laceration(s) 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Unspecified Infection 23 23
Low Blood Pressure/ Hypotension 21 21
Injury 21 21
Hypersensitivity/Allergic reaction 18 18
Vomiting 17 17
Nausea 17 17
Fatigue 17 17
Dizziness 17 17
Fever 16 16
Blood Loss 15 15
Discomfort 14 14
Swelling 14 14
Visual Impairment 14 14
Injection Site Reaction 13 13
Inflammation 13 13
Fall 12 12
Skin Inflammation/ Irritation 12 12
Reaction 12 12
High Blood Pressure/ Hypertension 12 12
Headache 11 11
Complaint, Ill-Defined 11 11
Overdose 11 11
Eye Injury 11 11
Malaise 10 10
Skin Tears 10 10
Vitreous Floaters 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Access Scientific LLC II May-14-2020
2 Allison Medical, Inc. II Dec-13-2022
3 Allison Medical, Inc. II Nov-18-2022
4 Arrow International Inc II Jan-24-2020
5 B. Braun Medical, Inc. II Sep-27-2023
6 Becton Dickinson & Company II Mar-10-2023
7 Becton Dickinson & Company II Feb-12-2021
8 Becton Dickinson & Company II Jul-22-2019
9 Cadence Science, Inc. II Nov-13-2019
10 Cardinal Health 200, LLC I Feb-02-2024
11 Cardinal Health 200, LLC I Oct-26-2023
12 Cardinal Health 200, LLC II Oct-13-2023
13 Cypress Medical Products LLC II Sep-16-2024
14 Cypress Medical Products LLC II Aug-29-2024
15 Fresenius Medical Care Holdings, Inc. I Oct-06-2023
16 ICU Medical, Inc. II Dec-23-2020
17 Jiangsu Shenli Medical Production Co., Ltd. II May-20-2024
18 LINEAGE BIOMEDICAL, INC III Aug-08-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
21 MEDLINE INDUSTRIES, LP - Northfield II May-31-2024
22 MICROVENTION INC. II Nov-04-2021
23 Mckesson Medical-Surgical Inc. Corporate Office II Jun-07-2024
24 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
25 Medela Inc III Jul-23-2019
26 Sol-Millennium Medical Inc. II Sep-06-2024
27 Stradis Healthcare II Jan-11-2023
28 Wolf, Henke Sass, Gmbh II Sep-27-2023
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